Biocompatibility testing for medical devices

Measurlabs offers an extensive range of accredited and GLP-certified biocompatibility tests conducted according to the ISO 10993 standard family. Our experts can also help formulate an appropriate testing strategy for your device.
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Our selection of ISO 10993 testing services

Measurlabs can offer most tests within the ISO 10993 standard family. For new medical devices, at least the following four core tests are typically required for market approval:

We also offer additional analyses for evaluating further biocompatibility endpoints, such as hemocompatibility (ISO 10993-4), pyrogenicity (ISO 10993-11), and genotoxicity (ISO 10993-3). Both in vitro and in vivo testing options are available for many of the endpoints.

The appropriate testing strategy is always decided on a case-by-case basis, based on the device's composition, intended use, and associated risks. The recommended way to start is to create a Biological Evaluation Plan (BEP), which evaluates these risks in a structured manner and outlines the tests required to assess them. We can help prepare the BEP, as well as the Biological Evaluation Report (BER) to summarize the results of the biocompatibility evaluation.

Do not hesitate to contact our experts for more information and a quote for your device. You can also book a free 30-minute biocompatibility kick-off meeting to discuss your testing needs with us in more detail.

Elina Tenhunen

Questions?

Elina Tenhunen and our other Medical Device Testing Experts are happy to help.

Beyond biocompatibility: full suite of medical devices testing services

In addition to ISO 10993 biocompatibility assessments, Measurlabs' service selection includes medical device packaging validation, bacterial endotoxin testing, cleaning validation, bioburden and sterility evaluations, and mechanical testing.

The tests are performed in our ISO 17025-accredited and GLP-certified partner laboratories. This ensures that you get the test reports in a format suitable for EU MDR conformity assessments and US FDA premarket submissions.

You will also get all the necessary support from our testing experts throughout the process. With their help, you can reduce the time spent on navigating regulatory requirements and method selection, freeing valuable resources for other important projects.

Why choose Measurlabs?

Widest range of testing methods – get all your tests done in the same place.

Best laboratories – for every test, we have sourced the best lab for that particular method, which means that you get the most accurate results and the best price.

Personal service – get help from method experts if you are unsure about standards, your testing needs or sample suitability.

Get a quote

Fill in the form, and we'll reply in one business day.

Answering the following questions helps us prepare an offer for you faster:

  • What is the intended use of your medical device? How does it contact the body, and how long is the contact duration?

  • Have you already determined which tests should be conducted on your device?

  • Do you need the tests for R&D purposes or for submission to officials?

Have questions or need help? Email us at or call our sales team.